NCT00336921已完成2 期
A Double-blind, Randomized,Placebo Controlled Study of Alfuzosin 10mg od in the Return to Successful Voiding in Patients With a First Episode of Acute Urinary Retention Due to Benign Prostatic Hyperplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Percentage of patients with successful voiding after catheter removal
研究概览
简要总结
The primary objective of the study is to assess the efficacy of alfuzosin 10mg daily in the return to successful voiding after removal of the catheter following a first episode of acute urinary retention (AUR) in patients suffering from benign prostatic hyperplasia (BPH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •First episode of painful AUR related to BPH requiring catheterization
- •Residual volume between 500ml and 1500ml obtained at the time of catheterization and during the first one hour after catheterization
排除标准
- •Participated in another investigational study within 3 months before recruitment
- •Suspect bladder neuro-dysfunction unrelated to etiology;
- •Single Bladder neck disease;
- •Acute/chronic prostatitis;
- •Diagnosed prostate carcinoma;
- •Suspected prostate carcinoma diagnosed by ultrasound wave;
- •Surgical history of prostate and urethra;
- •Diagnosed/suspected abnormality in urethra structure;
- •Bladder stone;
- •Blood urine retention caused by any reason;
- •Residual volume less than 500 ml
- •Residual volume more than 1500 ml
- •AUR not due to BPH
- •Parkinson's disease
- •Insulin dependent diabetes
- •Known/suspected multiple sclerosis;
- •Stroke/MI within 6 months prior to enrolment;
- •AST, ALT and Creatinine > 1.5x upper limit; neutrophil < 3,000/mm³; platelet < 100,000/mm³;
- •Unstable/severe heart failure;
- •History of postural hypertension/hypotension;
- •Known hypersensitivity to α-receptor blocker;
- •Suspected/diagnosed expansible nerval disease;
- •Treatment with sympathomimetic agent within 1 week prior to enrolment, except OTC drug for cold intermittently;
- •Treatment with α1-receptor blocker within 1 month prior to enrolment;
- •Treatment with tricyclic antidepressants, anticholinergic agents, sympathomimetic agent (other than the above reason), first generation antihistaminic, except the treatment with stable β sympathomimetic agent/ anticholinergic agents lasting more than 1 week for Asthma and COPD (Chronic Obstructive Pulmonary Disease);
- •Treatment with Disopyramide
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Active Comparator
Alfuzosin 10mg
干预措施: Alfuzosin (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of patients with successful voiding after catheter removal
时间窗: Day 3 and 4
Adverse events
时间窗: From the beginning to the end of the study
次要结局
未报告次要终点
研究者
研究点 (1)
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